Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of hu007 eye drops in patients with dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: a multicenter, randomized, double blind, restasis®-controlled non-inferiority, moisview® eye drops-controlled superiority, phase iii study to evaluate the efficacy and safety of hu007 eye drops in patients with dry eye syndrome


Eligibility criteria:
inclusion criteria: * age over 19 * corneal staining score(oxford grading) ≥ 2 or schirmer test ≤ 10mm/5min (if schirmer test = 0mm/5min, nasal stimulation schirmer test ≥ 3mm/5min) * volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception exclusion criteria: * the patients with systemic or ocular disorders affected the test result * current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status * being treated with systemic steroid * wearing contact lenses within 72 hr of screening visit * pregnancy or breastfeeding
developing and testing an online pathway from screening to treatment for depression in oncology: ipath*d (aim 2)

Conditions: Cancer; Depression

Summary: the purpose of this study is to determine the extent to which an online pathway to depression treatment (ipath\*d) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression.

the investigators will determine the extent to which an online pathway to depression treatment (ipath\*d) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression. ipath\*d will be designed to increase screening, mental health literacy, and treatment access. patients will access their ipath\*d account online to review their phq-9 score and its interpretation, followed by an interactive depression decision aid comparing information on a range of online and in-person treatment options. upon review of the decision aid, participants will be able to directly connect to a treatment path via embedded hyperlinks in the decision aid. the investigators will determine the usability, acceptability, and feasibility of ipath\*d. the investigators will explore the hypothesis that ipath\*d will be highly usable, acceptable to patients, feasible to implement, and will result in improved mental health literacy, and greater treatment access. the tool for the study was developed during a preliminary portion (aim 1) of the project, under d-h irb number study02001240 . this approach uses an open-label, single arm pilot, with adult patients receiving treatment for cancer in a rural cancer clinic, st johnsbury, vt (dartmouth cancer center north) (n=30) with moderate-severe depression, aim 2 of the project.

Eligibility criteria:
inclusion criteria 1. adults (≥18 years) 2. new patients who are beginning treatment at dartmouth cancer center north and returning for their chemo teach or radiation simulation visit 3. can communicate in english 4. phq-9 ≥10 and ≤27 exclusion criteria 1. mild depression (phq-9 ≥10) 2. individuals who screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6 on the columbia-suicide severity rating scale (c-ssr). 3. individuals with bipolar disorder or psychosis (documented in the emr) 4. individuals currently receiving treatment for a mental health condition (documented in the emr or self-reported during eligibility screening) 5. significant cognitive impairment (callahan's six item screener of cognitive function ≤ 4; self-reported during eligibility screening)

Keywords: shared decision making decision aid depression
prevalence of subclinical vertebral fractures in rheumatoid arthritis and ankylosing spondylitis

Conditions: Vertebral Fracture

Summary: study of prevalence of subclinical vertebral fractures in rheumatoid arthritis and ankylosing spondylitis

detection of the prevalence of subclinical vertebral fractures in rheumatoid arthritis and ankylosing spondylitis study the relation between vertebral fractures and some clinical data like demographics data, disease duration and disease severity

Eligibility criteria:
inclusion criteria: * patients fulfilling acr/eular 2010 rheumatoid arthritis classification criteria. patients diagnosed as ankylosing spondylitis according to asas criteria (2000). age (18-50). exclusion criteria: * patient with other autoimmune rheumatic disease other than ra and as. infections including hepatitis c or b, hiv, tuberculosis. ra and as patients with known vertebral fractures. malignancy, hypogonadism, thyroid problems, chronic kidney disease, hypoparathyroidism, type 1 dm. pregnancy and breast-feeding.
the combination of atra and eltrombopag as the treatment of steroid-resistant/relapse itp based on msc-c5b-9

Conditions: Purpura, Thrombocytopenic, Idiopathic

Summary: a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of atra plus eltrombopag compared to eltrombopag monotherapy in the treatment of steroid-resistant/relapsed immune thrombocytopenia (itp).

the investigators are undertaking a parallel group, multicenter, randomized controlled trial of patients with itp in china. patients were tested for mscs, and they were divided into msc-c5b-9+ group and msc-c5b-9- group according to the test results, and the two groups were randomized to atra + eltrombopag and eltrombopag monotherapy group. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: * 1. isolated thrombocytopenia (platelet count \ 18 years; 3. normal white blood cells and red blood cells on bone marrow examination; 4. increased number of megakaryocytes (bone marrow examination was performed in all patients except for myelofibrosis or other conditions that can cause thrombocytopenia disease); 5. the spleen was normal in size; 6. eastern cooperative oncology group status score (ecog score) ≤ 2; 7. ineffective or relapsed after at least 1 course of full-dose full-course hormone therapy; 8. failure of prior itp therapy (eg, hormones, splenectomy, and cyclosporine) and at least 4 weeks from enrollment. exclusion criteria: * 1. secondary itp such as drug-related thrombocytopenia; 2. thrombocytopenia due to viral infection (hiv, hepatitis b virus, or hepatitis c virus); 3. severe cardiac, renal, hepatic, or respiratory insufficiency; 4. severe immunodeficiency; 5. pregnancy or lactation; 6. myelodysplasia or myelofibrosis; 7. history of malignancy; 8. ongoing immunosuppressive therapy for other diseases; 9. patients previously treated with eltrombopag were excluded from this study.

Keywords: resistant/recurrent itp msc-c5b-9 marker all-trans retinoic acid eltrombopag prospective clinical study
capacity (cardiac amyloidosis and physical activity) study

Conditions: Cardiac Amyloidosis

Summary: exercise training in patients with heart failure and preserved ejection fraction (hfpef) has been associated with an improvement in cardiorespiratory fitness and quality of life.

the atrium health cardiac rehabilitation program delivers a comprehensive approach to improve cardiac performance including supervised exercise programs and has the ideal infrastructure to offer cardio-oncology rehabilitation (core) to all our cancer patients in the future. currently neither core nor cardiac rehabilitation for hfpef are covered by insurance, and hence the targeting of a higher risk cancer and non-cancer population of cardiac amyloidosis patients to objectively measure the benefits of a supervised exercise program ultimately to expand eligibility to all cancer patients and shape the treatment and payor landscape in the future.

Eligibility criteria:
inclusion criteria: * age \> 18 * new york heart association (nyha) class i-iii heart failure * able to exercise * on stable treatment for their cardiac amyloidosis or under active surveillance * life expectancy of at least 6 months * ability to understand and the willingness to sign a written informed consent document in english, and the willingness/ability to comply with the protocol activities * participant must be able and willing to follow the cardiac rehabilitation activities exclusion criteria: * inability to provide informed consent * inability to commit to in-person supervised exercise sessions for three one-hour sessions a week for 12 weeks * nyha class iv heart failure * pulmonary disease requiring home oxygen * gait instability or history of prior falls * in the opinion of the principal investigator, have a clinically significant comorbid disease that is likely to affect the ability of the patient to complete the trial, interfere with their ability with measurement of self-reported outcomes.

Keywords: heart failure preserved ejection fraction cardiac rehabilitation
the application of traditional chinese medicine functional reduction in muscle fatigue

Conditions: Muscle Fatigue

Summary: in this study, 45 healthy participants between 20 and 40 of age will be included. after obtaining the consent, the participants will be categorized into two(a\&b) groups randomly for cross-over study. each of group will accept either conventional taping or chinese medicine technique taping before muscle fatigue exercise. to compare the preventive effect, myoton pro, pulse analysis equipment, etc will be applied for evaluation. the application of chinese medicine technique (ie. chinese medicine functional reduction) taking the kinetic chain into consideration may improve body's functional movement.

nowadays, the importance of exercise is highly valued. the prevalence of sports injury is also increasing and may be associated with muscle fatigue. therefore, the study focused on the prevention of common muscle fatigue in legs during exercise. with the modern sport medicine knowledge and kinesio taping, the investigators tried to figure out whether muscle fatigue can be diminished through the concept of chinese medicine channel sinews techniques in advance. in this study, 45 healthy participants between 20 and 40 of age will be included. the exclusion criteria are as follows: i.pregnancy ii.current health problem iii.injuries of legs within a month. after obtaining the consent, the participants will be categorized into two(a\&b) groups randomly for cross-over study. each of group will accept either conventional taping or chinese medicine technique taping before muscle fatigue exercise. to compare the preventive effect, myoton pro, pulse analysis equipment, etc will be applied for evaluation. the application of chinese medicine technique (ie. chinese medicine functional reduction) taking the kinetic chain into consideration may improve body's functional movement. our goal is to enhance the coordination of the entire body structure, not merely the partial body structure improvement. in this way, it will benefit the prevention of exercise injuries and therapeutic effect.

Eligibility criteria:
inclusion criteria: * participants between 20 and 40 of age exclusion criteria: * i.pregnancy ii.current health problem iii.injuries of legs within a month

Keywords: taping chinese medicine reduction muscle fatigue
initiation of cooling by ems to promote adoption of in-hospital hypothermia in cardiac arrest survivors

Conditions: Out of Hospital Cardiac Arrest

Summary: this is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by emergency medical services (ems) providers to conventional post-resuscitation care. the goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. the investigators believe that ems-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system.

this is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by emergency medical services (ems) providers to conventional post-resuscitation care. the goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. the investigators believe that ems-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system. this study builds on our previous work using large hospital networks hospitals to improve the delivery of evidence-based practice. the primary research question is as follows: does pre-hospital initiation of therapeutic hypothermia by ems providers increase the proportion of comatose out of hospital cardiac arrest patients with return of spontaneous circulation (rosc) that are successfully cooled to a target temperature of 32 to 34 degrees celsius within 6 hours of emergency department arrival, compared to usual post-resuscitation care provided in the field? the primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees celsius within 6 hours of emergency department arrival.

Eligibility criteria:
inclusion criteria: * pulseless ohca in the study communities (any rhythm, initial rhythm will be recorded) * age equal to or greater than 18 years * defibrillation and/or chest compressions by ems providers (including fire fighters) * return of spontaneous circulation (rosc) sustained for greater than or equal to 5 minutes * patient is unresponsive to verbal stimulus using avpu (alert, voice, pain, unresponsive) scale * patient is endotracheally intubated * sbp equal to or greater than 100 mm hg (even if needing dopamine) exclusion criteria: * trauma (including burns) associated with cardiac arrest * sepsis or serious infection suspected as cause of cardiac arrest * clinical evidence of active severe bleeding * suspected hypothermic cardiac arrest * known coagulopathy (medical history or medications; asa and clopidogrel are permitted) * any verbal or written do-not-resuscitate (dnr) * obviously pregnant * known prisoner

Keywords: therapeutic hypothermia cardiac arrest
clinical implications of azole-resistant aspergillosis in hematological malignancy

Conditions: Invasive Aspergillosis

Summary: in order to determine the efficacy of antifungal therapy in patients with documented azole-resistant invasive aspergillosis (ia), anonymized clinical information of patients with a hematological malignancy with a culture-positive invasive fungal infection caused by aspergillus fumigatus are collected in an online registry. respective fungal isolates are analysed for azole susceptibility and resistance mechanisms. patients diagnosed with an ia in 2016 and later are included in the study.

for mold-active azoles (e.g. isavuconazole, itraconazole, posaconazole and voriconazole), cross-resistance of aspergillus spp. is an increasingly recognized problem. the study aims to determine the efficacy of antifungal therapy in patients with documented azole-resistant ia. on the basis of this study, it will be possible to assess the clinical implications of ia caused by azole-resistant versus azole-susceptible aspergillus spp. the investigators aim at collecting at least 55 azole-resistant and 130 azole-susceptible cases. cases diagnosed with an ia by culture from january 1st, 2016 onwards with an underlying hematological malignancy are eligible for inclusion. culture of azole-resistant cases must be provided for confirmation of the species, sequencing for azole-resistance mutations and determination of mic using the eucast reference method. isolates obtained from patients with presumed azole-susceptible disease will be analyzed to confirm the wild type phenotype. eligible azole-resistant and azole-susceptible ia cases will be documented using the web-based case report form. if there is ≥1 resistant isolate, the patient fulfills the definition of a resistant case. patient level data will be recorded at the respective study centres in a continuous fashion. data items to be documented will include: demographic data; type and status of underlying conditions; concurrent immunosuppressive treatment; diagnostic measures (clinical presentation, radiology, microbiology, pathology, organ involvement); medical and surgical treatment (including prior exposure to antifungals); response to treatment (clinical and radiological) at day 14, 42, 84; overall survival at day 14, 42, 84 and at last contact; and cause of death (if applicable).

Eligibility criteria:
inclusion criteria: * adult and pediatric patients diagnosed with an ia in 2016 and later * patients with a hematological malignancy * evidence of invasive aspergillosis * aspergillus fumigatus culture from clinical material of the patient exclusion criteria: * colonization only, without proof of invasive infection * non-availability of the azole resistant isolate

Keywords: invasive aspergillosis azole resistance aspergillus fumigatus efficacy of antifungal therapy patient registry
does coffee consumption prevent or shorten postoperative ileus after colon resection?

Conditions: Postoperative Ileus

Summary: the purpose of this study is to determine if consuming an 8 ounce cup of coffee with breakfast and lunch is effective in preventing or reducing postoperative ileus.

recent evidence has shown that a multimodal rehabilitation program can accelerate recovery of gi function after colon resection. 8 a multicenter, randomized, placebo-controlled, double-blind, phase 3 trial demonstrated that alvimopan, a peripherally acting mu-opioid receptor antagonist, appears to accelerate gi tract recovery by 1 day, and reduces postoperative ileus-related morbidity without compromising opioid analgesia. 9 asao et al demonstrated that gum chewing can accelerate recovery of gi function, also by 1 day, after abdominal surgery. 10 epidural anesthesia has been shown to shorten duration of poi, as well as improve pain control, decrease pulmonary complications, and quicken recovery times. however, it does not appear to reduce overall length of stay. 4 however, neudecker et al. were unable to reproduce the results of previous trials evaluating the effect of thoracic epidural analgesia on duration of postoperative ileus following laparoscopic sigmoid resection. 11 given conflicting data, no one single measure has been adopted for the prevention poi. recent evidence has shown that coffee may be a stimulant for the gi tract. a small study of 16 healthy volunteers demonstrated that coffee appears to increase rectal tone thus implying an impact on defecation mechanics.12 furthermore, several studies have demonstrated caffeinated coffee to be a stimulant of motor activity in the colon.13,14 given its potential pro-motility properties in the gi tract, it seems reasonable to postulate that coffee, a commonly consumed product by the general public, may play a role in shortening and possibly preventing poi. this directly impacts overall patient satisfaction but will reduce length of stay and overall hospital costs.

Eligibility criteria:
inclusion criteria: * elective partial bowel resection with primary anastomosis for either cancer or benign disease. * laparoscopy or laparotomy exclusion criteria: * total colectomy * colostomy * ileostomy * reversal of a stoma or synchronous resection * complete small or large bowel obstruction * scheduled to receive other treatments or techniques to reduce ileus 1. epidural anesthetic tecniques * nasogastric tube for any length of timein the post-op period.
the effect of postoperative abdominal binder to improve outcomes after incisional hernia repair

Conditions: Incisional Hernia

Summary: postoperative seroma formation is one of the most common complications after ventral hernia repair with mesh. although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. abdominal binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (ab) are commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain and discomfort after operation. the primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic incisional hernia repair on postoperative pain, discomfort and quality of life. secondary, we register seroma formation. a randomized, controlled, investigator-blinded study supplemented with blinded statistical analysis. we include 60 (2x30) incisional hernia repairs. patients are randomized either to abdominal binder or no abdominal binder (controls). the abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. all patients have a standardized operation with standardized intra- and postoperative medication regimen. endpoints measurements are clinically detectable seroma formation scored with seroma classification system buý s. morales-conde, pain scored with self-registrations with vas, and quality of life scored with eq-5d, recurrence and other complications are also registered. patients are followed until 90 days after the operation.


Eligibility criteria:
inclusion criteria: * elective, primary and recurrent laparoscopic and open incisional hernia repair hernia with mesh reinforcement * fascia defects 6-20 cm measured preoperatively by the surgeon at the out-patient clinic * patients between 18-80 years exclusion criteria: * expected low compliance (language problems, dementia and abuse etc.) * fascia defects \>20 cm measured at the preoperative clinical examination. * acute operation * decompensated liver cirrhosis (child-pugh 3-4) * patients with a stoma * if a secondary operation is performed during the hernia repair procedure. * if a patient withdraws his inclusion consent
etiologies of fever among adults in dar es salaam

Conditions: Acute Febrile Illnesses

Summary: following the decline of malaria in sub-saharan africa, clinicians face febrile patients in whom an alternative diagnosis has to be made. this situation has led to an overuse of antibiotics by clinicians. it is crucial to increase knowledge on etiologies and risk factors of outpatient febrile illness in order to improve their management. this present proposal aims to investigate the etiologies of fever among adult patients attending an outpatient department in urban tanzania. it also aims to assess the clinical significance of nasopharyngeal (np) respiratory viruses and bacteria documentation in this setting. third, it aims to compare the spectrum of infections in this population with that of children included in the same setting in a previous study. the last objective is to assess diabetes mellitus (dm) as a risk factor for infection and exposure to indoor air pollution (iap) as a risk factor for acute respiratory infections (ari) in adults in tanzania. the investigators hypothesize that acute respiratory infections are the main cause of adult febrile illness in a urban low-income setting and that use of quantitative molecular assays on naso-oropharyngeal samples can improve the diagnosis of pneumonia. the investigators also think that the spectrum of infections is different between children and adults, mainly due to a high hiv prevalence in adults. the investigators also hypothesize that experiencing iap and/ or dm is a risk factor for infections in adults.


Eligibility criteria:
inclusion criteria: * temperature \>=38°c * history of fever for less than 8 days * first consultation for the present problem exclusion criteria: * refusal of hiv screening * main complaint is injury or trauma * antibiotic treatment in the last 7 days * within 6 weeks after delivery * hospitalization during the last month

Keywords: fever tanzania pneumonia hiv diabetes indoor air pollution